BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3897051 · Received June 26, 2014

    Report

    Report Number
    2520274-2014-11881
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ZSOLDOS, C.M., BASAMANIA, C.J., AND BAL, G.K. (2013). SHOULDER FUSION AFTER A SELF-INFLICTED GUNSHOT WOUND. BONE JOINT J, 95-B(6), 820-824. THIS REPORT IS FOR AN UNKNOWN PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ZSOLDOS, C.M., BASAMANIA, C.J., AND BAL, G.K. (2013). SHOULDER FUSION AFTER A SELF-INFLICTED GUNSHOT WOUND. BONE JOINT J, 95-B(6), 820-824. THE AUTHORS PRESENTED A CASE SERIES OF SEVEN PATIENTS WHO SUSTAINED A SEVERE SHOULDER INJURY TO THE NON-DOMINANT SIDE AS A RESULT OF A SELF-INFLICTED GUNSHOT WOUND. BETWEEN 2002 AND 2008, THE TWO SENIOR AUTHORS (CJB, GKB) TREATED SEVEN PATIENTS WITH THE SAME PATTERN OF INJURY ¿ A SELF-INFLICTED GUNSHOT WOUND TO THE SHOULDER THAT OCCURRED DURING A SUICIDE ATTEMPT. ALL PATIENTS WERE MALE, WITH A MEAN AGE OF 32 YEARS (21 TO 48). ALL WERE TREATED AT THE TIME OF INJURY WITH INITIAL REPEATED DEBRIDEMENT, AND WITHIN FOUR WEEKS EITHER BY HEMIARTHROPLASTY (FOUR PATIENTS) OR ARTHRODESIS (THREE PATIENTS). PATIENT NUMBER SIX WAS A (B)(6) MAN WHO SUSTAINED A SELF-INFLICTED GUNSHOT WOUND TO THE LEFT SHOULDER USING A HUNTING RIFLE. BECAUSE OF THE PATIENT¿S YOUNG AGE AND EMPLOYMENT AS A LABOURER, AN ARTHRODESIS OF THE SHOULDER WAS SELECTED AS THE INITIAL RECONSTRUCTIVE PROCEDURE. THE SHOULDER WAS FUSED USING A SYNTHES 4.5 MM LOCKING RECONSTRUCTION PLATE. AT 4.5 MONTHS POST-OPERATIVELY HE COMPLAINED OF PERSISTENT PAIN OVER THE PROXIMAL HUMERUS. RADIOGRAPHS REVEALED A FRACTURED PLATE AND PROBABLE NONUNION OF THE ARTHRODESIS. THE BROKEN HARDWARE WAS REMOVED, THE NONUNION SITE WAS DEBRIDED, AND A REVISION OF THE FUSION WAS PERFORMED. ALL FOUR HEMIARTHROPLASTY IMPLANTS WERE REMOVED WITH NO FEASIBLE RECONSTRUCTION ULTIMATELY POSSIBLE, RESULTING IN A POOR FUNCTIONAL OUTCOME AND NO RETURN TO WORK. IN CONTRAST, ALL THREE PRIMARY ARTHRODESES EVENTUALLY UNITED. THESE PATIENTS RETURNED TO WORK WITH A GOOD FUNCTIONAL OUTCOME. THE AUTHORS RECOMMEND ARTHRODESIS RATHER THAN REPLACEMENT AS THE TREATMENT OF CHOICE FOR THIS CHALLENGING INJURY. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS COMPLAINT INVOLVES ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374913 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention